NIH FCOI FAQs

Click here for the NIH FAQ page covering revised federal regulations regarding the Responsibility of Applicants for Promoting Objectivity in Research for which PHS Funding is Sought, applicable to grants and cooperative agreements.

Who must disclose on the Summary Disclosure of Financial Interests (SDFI) form?

All individuals responsible for the design, conduct, or reporting of the results of work performed or to be performed under the sponsored project, referred to as "Investigator." "Investigator" includes, but is not limited to the Principal Investigator, Co-Investigators, and any other individuals (including personnel from other institutions) who are involved in accomplishing project objectives. It may include students, graduate and undergraduate, and other personnel who may be listed as authors on project results, even if they are not paid from the project.

If you have questions as to whether you are required to disclose on the SDFI, please contact Research Funding Services at research.funding@umassmed.edu.

When do I have to file a SDFI form?

The Principal Investigator (PI) and each Investigator must complete and sign the Summary Disclosure at the proposal submission stage and confirm no change in status at the point of each award. Investigators are required to update their disclosures annually or whenever a new significant (greater than $5,000 in the preceding 12 months) financial interest is received.

When do I have to update my Disclosure?

Your disclosure needs to be updated in the UMMS COI System (http://coi.umassmemorial.org/coi/) within 30 days of discovering or acquiring a new Significant Financial Interest. Otherwise, you update and submit your disclosure as part of the annual submission on the UMMS COI System.

What types of activities do I have to disclose?

You must disclose any activities or financial interests that might reasonably appear to be related to any of your institutional responsibilities. This would include any interests in any company or business that:

funds your research through sponsored research agreements, gifts or any other funding arrangement;

provides materials or other in-kind support (e.g., drugs, devices, other tangible items) for your research;

holds an Investigational New Drug application (IND) or Investigational Device Exemption (IDE) for the research being performed;

owns, licenses or has any financial interest in your research or;

acts for or on the behalf of another company. This may include some medical education companies or other similar entities.

What is a "Significant Financial Interest"?

Any of the following payments are Significant Financial Interests:

With regards to Publicly-Traded Entities, payments or value exceeding $5,000 when aggregated for an Investigator and the Investigator's spouse/domestic partner and dependent children from a single entity, including salary, consultant payments, honoraria, paid authorship, equity interest (stock, stock option or other ownership interest) during the prior 12 months.

With regards to Privately Held Entities, payments or value exceeding $5,000 when aggregated for an Investigator and the Investigator's spouse/domestic partner and dependent children from a single entity during the prior 12 months or when the Investigator and the investigator's spouse/domestic partner and dependent children hold any equity interest (stock, stock option, or other ownership interest).

With regards to Intellectual Property, intellectual property rights and interests (patents, copyrights) upon receipt of income related to such rights and interests.

With regards to Travel Reimbursements, any reimbursed or sponsored travel related to the Investigator's Institutional Responsibilities during the prior 12 months (with the exception of travel that is reimbursed or sponsored by a Federal, state, or local government agency, an institution of higher education, an academic teaching hospital, a medical center, or a research institute that is affiliated with an institution of higher education. Are there financial interests I don't have to disclose?

The term "Significant Financial Interest" does not include: salary, royalties, or other remuneration paid by the University to the Investigator if the Investigator is currently employed or otherwise appointed, including intellectual property rights assigned to the Institution and agreements to share royalties related to such rights; income from investment vehicles, such as mutual funds and retirement accounts; income from seminars, lectures, or teaching engagements sponsored by a Federal, state, or local government agency, an institution of higher education, an academic teaching hospital, a medical center, or a research institute affiliated with an institution of higher education; or income from service on advisory committees or review panels for a Federal, state, or local government agency, an institution of higher education, an academic teaching hospital, a medical center, or a research institute affiliated with an institution of higher education.

Who determines if I have a conflict of interest?

What happens if I do have a conflict of interest?

If it is determined that a conflict of interest exists, a Management Plan will be created to manage the conflict. All approved Management Plans are developed, reviewed, approved, and annually monitored by the university’s COI Officer, the Associate Vice Provost for Research, working as needed with the University Conflicts Committee. Management Plans are reviewed annually for renewal and are effective as long as the conflict is present. If a Significant Financial Interest relating to your Institutional Responsibilities is determined to constitute a Financial Conflict of Interest with respect to a PHS-funded activity, the appropriate report describing the Management Plan shall be submitted to the funding agency by UMMS.

What about financial interests relating to a human-subjects study?

Any project that involves human-subjects research is subject to the requirements of the University of Massachusetts Guidelines for the Oversight of Individual and Institutional Financial Interests in Human Subjects Research ("Human Subjects Guidelines"). Any amount of remuneration or any equity ownership related to a human-subjects study requires additional reviews and oversight. Click here for the policy.